Stem Cell Buzz May Help Industry

Stem cell companies may benefit from the buzz surrounding the field generated by the anticipated clash between Congress and President Bush and increased regulatory attention being given to adult stem cell products.

Companies focused on embryonic stem cell therapeutics have issued releases about their research recently in an apparent attempt to capitalize on the increased attention on the field after the House passed legislation last week that would relax restrictions on federal funding for the research.

Both chambers of Congress passed a similar bill last year, but Bush vetoed it and is expected to continue his opposition this year. House Democrats last week were hopeful they could garner enough votes to override a veto, but they fell short of the votes they would need to do so.

Advanced Cell said Wednesday it plans to hold a conference for investors on Friday to "to discuss recent progress and events with respect to the company's initiatives to develop stem cell-based therapies for a range of diseases and conditions."

Geron said Wednesday new research indicates GRNOPC1, a potential human embryonic stem cell-based therapeutic for spinal cord injury, produces multiple nerve growth factors that stimulate survival and regeneration of damaged neurons in animal models.

The FDA issued a draft guidance for a streamlined path to licensure for cord blood products for certain medical conditions, such as replenishing the bone marrow in patients with leukemia.

"Cord blood hematopoietic stem/progenitor cells offer the potential for tremendous therapeutic benefit," said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "In this draft guidance, FDA provides recommendations on a streamlined path to licensure for these promising products that also ensures their safety and effectiveness."

Under the draft guidance, cord blood banks can cite existing data in the docket to support licensure for certain indications rather than having to provide their own clinical data. The FDA said it was proposing this strategy because it has determined cord blood hematopoietic stem/progenitor cells are safe and effective for certain indications based on data submitted to the public docket and published scientific research.

Advanced Cell said during its Friday conference call William Caldwell IV, its chairman and chief executive officer, will provide an overview of the company's activities and will comment on the effect the political climate is having on stem cell research.

This includes not only the federal debate, but favorable legislation for the research passed by certain states, such as California and New Jersey. Advanced Cell also noted that Eliot Spitzer, who was recently elected governor of New York, called for passage of a research-and-development bond that would provide $2 billion over a 10-year period, at least half of which would go towards stem cell work.